Edge Pharma recalls 4% Tetracaine HCl Nasal Solution due to CGMP deviations. This may affect safety and quality of the product. Consumers should check their bottles for NDC 05446-1195-03.
CGMP Deviations
Edge Pharma is recalling 4% Tetracaine HCl Nasal Solution bottles that may have manufacturing quality issues. This recall is due to deviations in current Good Manufacturing Practices (CGMPs), which could affect product safety and quality.
CGMP deviations refer to failures in the manufacturing process that could lead to product quality issues. This might mean the nasal solution isn't safe or effective as intended. However, the specific risks aren't detailed in the recall notice.
People who own or use the recalled Tetracaine HCl Nasal Solution bottles with NDC 05446-1195-03 are affected. Those using the product for nasal procedures may be at higher risk due to potential quality issues.
Check for the NDC code 05446-1195-03 on the bottle label. The product is a 4% Tetracaine HCl Nasal Solution, 240 mL, multiple-dose container for intranasal use.
Look for the NDC code 05446-1195-03 on the bottle to confirm it's the recalled product.
The recall states there were CGMP deviations, but the specific safety risks aren't detailed. The product may not be safe or effective as intended.
Check for the NDC code 05446-1195-03 on the bottle label. The product is a 4% Tetracaine HCl Nasal Solution, 240 mL, multiple-dose container for intranasal use.
The recall does not specify a remedy, so there's no action required beyond checking the product label.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0447-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0447-2022 from Edge Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
